COMPLAINTS WITH DIRECTORATE OF FOOD AND DRUGS ADMINISTRATION, GOVERNMENT OF GOA
Online complaint to PG cell of Government of Goa was transferred to Food and Drugs Administration, Government of Goa :
Collusion by FDA Goa Director & DCG(I) with Cipla Ltd to silence the aggrieved to abort seeking justice in death of his wife is exposed as follows:
a) Letter was sent to Complainant by FDA Goa Director dated 16.04.2018 stating that explanation submitted by Cipla is sent to him which was self-explanatory [Evidence document page 137].
b) Letter from FDA Goa Director dated 15/05/2018 was sent to DCG(I) for necessary action at his end [Evidence document page 305]. Copy was sent to Dy. Drugs Controller (India) CDSCO (WZ), Mumbai.
c) After explanation by Cipla Head Global Pharmacovigilance was proved by me as fraudulent,
FDA Goa Director told the DCG(I) that the said complaint was investigated by Investigating Officer of their Directorate by visiting the premises and was reported that as per Cipla’s policy,
• All complaints related to adverse drug reaction are investigated at Drug Safety Department of Cipla at Mumbai.
• Subsequent follow up reports are submitted to Drugs Controller General (India) as per pharmacovigilance guidelines.
• The said adverse drug reaction case was not reported to their Directorate.
• Further firm was served with show cause notice and was personally heard in the matter.
• As it was a serious adverse drug reaction case, copy of complaint and submission from Cipla along with reply from Complainant on explanation submitted by Cipla was forwarded for information and necessary action at DCG(I) end.
d) Letter dated 03/21/2019 was sent to Cipla Ltd by FDA Goa Director [Evidence document page 306].
• That explanation submitted by Cipla was not satisfactory.
• That Cipla had failed to intimate their Directorate of serious Adverse Drug Reaction as required under Sub Para (2) of Para 28, Schedule M of Drugs and Cosmetics Rules.
• However, considering the assurance given by Cipla that such violation will not be repeated and on investigating the matter by the Inspecting Officer of their Directorate no adverse findings were reported in respect of quality of the product no action was taken against Cipla.
• However, Cipla was warned on the matter that if such lapses are reported on their part in future, then strict action as per provision of law will be taken against Cipla.
Note : Submissions by the Complainant on the above letter by FDA Goa Director to Cipla Limited:
• This letter dated 03/21/19 arrived suddenly and out of the blue, a year after Cipla was exposed for their fraudulent explanation vide Complainant’s letter dated 21.04.2018 to FDA Goa Director [Evidence documents pages 151-152].
• Correction to date of the letter is obvious and visible.
• Coincidence is to be noted seriously. This letter came after the Joint Investigation Report dated 20/03/2019 was submitted to the DCG(I) by CDSCO (WZ), Mumbai.
• The Joint Investigation Report has been proved as a farce by the Complainant.
• Only Warning, Even after death caused?
• Only Warning, Even after ‘Explanation was not Satisfactory’ ?
• Only Warning, Even after ‘Failing to report the serious ADRs’.
• Inspecting Officer was investigating the accused and how did the Investigating Officer got satisfied with explanation of the accused criminal offender? Any documents to substantiate Cipla’s claims?
• How could you determine lapses in quality of manufacturing four years after the death? And after two years of shelf life of the concerned batch in question was over in January 2016.
• ‘Clean Chit’ W/O investigation? What about investigation as per Schedule ‘M’ of Drugs and Cosmetics Rules?
• What about life of innocent sacrificed?
• FDA Goa Director did not deem it fit to question why the drug was not investigated and why protocol of Schedule M was not followed.
• FDA Goa Director tells the killer drug manufacturer that “If you kill again, strict action will be taken as per provision of the law”.
• Law regarding Drugs and Cosmetics Act, 1940 was in place and was applicable to all the states of India.
• Why was this law deferred by the Director, Directorate of Food and Drugs Administration, Government of Goa to an unscrupulous pharma company playing with lives of the citizens of India.
• What if a loved one of FDA Goa Director was the casualty? Would the killer still be pardoned till he commits the homicide again in the future?
e) Letter to Complainant by FDA Goa Director dated 15/05/2019 [Evidence document page 307].
• It says that the matter was investigated by the Inspecting Officers of their Directorate and it was reported that there are no lapses on the part of the firm as regards quality of the drug of batch in question.
• However the firm had failed to intimate their Directorate regards the serious adverse event.
• Hence firm was issued Show Cause notice and explanation was called.
• Thereafter warning was issued as they had failed to intimate the Directorate regarding serious Adverse Drug Reaction as per requirements of Drugs and Cosmetics Rules 1945 (Copy of warning enclosed).
Note : Submissions by the Complainant to the above letter by FDA Goa
Director dated 15/05/2019 to the Complainant :
• FDA Goa Director trusted the words of the Inspecting Officer who in turn was investigating a homicide case and trusted the words of the accused even after being deceived by Cipla Head Global Pharmacovigilance with ‘Fake Chemistry’ and ‘Fake Medical Theses’.
• Warning was issued to the accused but what about lives of the survivors of the deceased?
• Both Cipla Board of Directors as well as regulatory authority, FDA Goa are one family playing with lives of citizens and amassing ill-gotten wealth.
f) Letter to Complainant by Mr. Somnath Basu, Assistant Drugs Controller (India) dated 23/05/2019 [Evidence document page 308].
• That the office had received Complainant’s offline grievance as on 26.03.2019 vide letter Nil dated 14.01.2019 on subject matter; Public grievance; Adverse drug reaction following administration of “Rokfos” branded Zoledronic acid (5mg/100ml) for infusion Mfgd. by M/s Cipla Ltd., Goa-reg.
• Reference was made to office letter dated 20.03.2019.
• That the case was under examination and active consideration with this office and Director, Food & Drugs Admn., Goa. The reminder latter dated 17.05.2019 has been issued to the Director, Food & Drugs Admn., Goa to take necessary action in this matter under intimation to their office at the earliest.
Note: Submissions by the Complainant on the above letter dated 23/05/2019by Assistant Drugs Controller (India) to the Complainant:
g) Complainant wrote a letter dated 12th June 2019 to the Director, Directorate of Food and Drugs Administration, Government of Goa seeking information on their letter dated 21st March 2019 to Cipla Limited and their letter dated 15/05/2019 to the Complainant [Evidence documents pages 309-314].
• It is more than four years and no reply has been submitted to the Complainant by FDA Goa Director.
• Clearly, the entire episode of death of my wife is a massive cover up by an unscrupulous pharma company in nexus with doctors, hospitals and top most civil servants in regulatory and law enforcement agencies of the country. This amounts to anti-national seditious acts.
h) Complaint was registered by the Complainant with the Chief Minister of Goa dated 21st December 2020 against FDA Goa Director and Inspection officers [Evidence documents pages 315-319]. Subject matter was as explained above.
• Complainant has not received any reply or acknowledgement for the complaint.
i) Complainant sent an RTI request dated 09th February 2021 for information from the Office of Chief Minister of Goa [Evidence documents pages 320-339]. Information requested were the following :
• Reason for not acknowledging my complaint.
• Action taken report in my complaint against the Director, Food and Drugs Administration, Government of Goa.
• Action taken against Cipla Ltd for death caused from their drug Rokfos manufactured at their Goa facility.
• Action taken against Cipla Ltd for violating statutory guidelines; Schedule ‘M’ of Drugs and Cosmetics Rules.
• Action taken against Cipla Ltd for suppressing the serious ADRs of injection Rokfos which caused death of the Complainant’s wife.
j) The RTI request was forwarded to the PIO of Directorate of Food & Drugs Administration, Bambolim, Goa.
Note : Who in FDA Goa can take action against FDA Director?